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Associate Director Global Regulatory Affairs
Requisition ID: 00001CA3
Janssen Research & Development, a member of Johnson &
Johnson's Family of Companies, is recruiting for an Associate Director, Global
Regulatory Affairs, Diagnostics. The position will be based in Raritan, NJ,
Titusville, NJ, Spring House, PA or Ontario, Canada.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Associate Director, Global Regulatory Affairs, Diagnostics will:
- Manages the coordination of submissions, and assist with the development of strategy for worldwide submission of new companion diagnostics In-Vitro Diagnostics (IVD) and medical devices to the regulatory agencies working with Dx partners and pharma.
- Specifically, for Companion Diagnostics, bridges requirements between Drug and IVD regulatory affairs and development teams.
- Contributes to the development and realization of business, e.g. by development of adequate regulatory strategies.
- Prepare or coordinate the preparation of submission documents.
- Provides guidance and support to product development teams on regulatory issues.
- Provide input on regulatory strategy changes and seek and summarize changes in regulations.
- Provide commenting input to policy team regarding regulatory guidance.
- Establish standard operational procedures to achieve efficiency within regulatory affairs, including the interfacing with other departments across MD&D, IVD and Drug development.
- Identify educational needs, set up training sessions, and provide information on applicable regulatory topics to involved personnel across applicable legal entities.
- Provide input to the management team in establishing short and long-term business strategic plans and objectives. Direct implementation of business strategic plans to achieve objectives.
- Responsible for participating in multidisciplinary teams of professionals located mainly in North America (US and Canada), but also globally, including Latin America, Asia Pacific and Europe.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
- Minimum is a Bachelor’s Degree is required.
- Minimum of 5 years of regulatory experience is required.
- Knowledge of global regulations for Medical Devices or In Vitro Diagnostics is required.
- General knowledge of regulations for Drugs is required.
- Familiarity with GCP, GMP, and clinical laboratory regulations and licensing is preferred.
- Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics is required.
- RAC certification is preferred.
- This position is located in Raritan, NJ, Titusville, NJ, Spring House, PA or Ontario, Canada and may require up to 20% travel.
United States-New Jersey-Raritan
North America-Canada-Ontario, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)